Trial Outcomes & Findings for Intracervical Lidocaine Gel for IUD Insertional Pain (NCT NCT01214161)
NCT ID: NCT01214161
Last Updated: 2016-04-07
Results Overview
Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
During IUD insertion (see above description for which time points)
Results posted on
2016-04-07
Participant Flow
Participant milestones
| Measure |
Lidocaine Gel
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intracervical Lidocaine Gel for IUD Insertional Pain
Baseline characteristics by cohort
| Measure |
Lidocaine Gel
n=100 Participants
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
n=100 Participants
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 6 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
72 participants
n=5 Participants
|
81 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Parity
Nulliparous
|
39 participants
n=5 Participants
|
21 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Parity
Parous
|
61 participants
n=5 Participants
|
79 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Dysmenorrhea
|
36.8 units on a 100mm Visual Analogue Scale
STANDARD_DEVIATION 29 • n=5 Participants
|
32.3 units on a 100mm Visual Analogue Scale
STANDARD_DEVIATION 28 • n=7 Participants
|
34.6 units on a 100mm Visual Analogue Scale
STANDARD_DEVIATION 28 • n=5 Participants
|
|
Anticipated pain
|
56.0 units on a 100 mm visual analogue scale
STANDARD_DEVIATION 26 • n=5 Participants
|
57.2 units on a 100 mm visual analogue scale
STANDARD_DEVIATION 28 • n=7 Participants
|
56.6 units on a 100 mm visual analogue scale
STANDARD_DEVIATION 27 • n=5 Participants
|
|
IUD type
Levonogestrel IUD
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
IUD type
Copper IUD
|
70 participants
n=5 Participants
|
68 participants
n=7 Participants
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During IUD insertion (see above description for which time points)Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
Outcome measures
| Measure |
Lidocaine Gel
n=100 Participants
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
n=100 Participants
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
|---|---|---|
|
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
Tenaculum placement
|
35.4 units on a 100 mm visual analogue scale
Standard Deviation 26
|
34.3 units on a 100 mm visual analogue scale
Standard Deviation 25
|
|
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
Uterine sounding
|
55.5 units on a 100 mm visual analogue scale
Standard Deviation 30
|
51.6 units on a 100 mm visual analogue scale
Standard Deviation 25
|
|
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
IUD insertion
|
51.0 units on a 100 mm visual analogue scale
Standard Deviation 31
|
50.9 units on a 100 mm visual analogue scale
Standard Deviation 32
|
|
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
Speculum removal
|
20 units on a 100 mm visual analogue scale
Standard Deviation 43
|
20 units on a 100 mm visual analogue scale
Standard Deviation 45
|
SECONDARY outcome
Timeframe: During IUD insertionOutcome measures
| Measure |
Lidocaine Gel
n=100 Participants
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
n=100 Participants
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
|---|---|---|
|
Adverse Events
Nausea
|
8 participants
|
4 participants
|
|
Adverse Events
Vomiting
|
0 participants
|
0 participants
|
|
Adverse Events
Dizziness
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: during IUD insertionThis secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.
Outcome measures
| Measure |
Lidocaine Gel
n=200 Participants
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
n=200 Participants
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
|---|---|---|
|
Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale
|
63.8 units on a 100 mm visual analogue scale
Standard Deviation 27
|
35.3 units on a 100 mm visual analogue scale
Standard Deviation 26
|
Adverse Events
Lidocaine Gel
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Gel (Surgilube)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine Gel
n=100 participants at risk
This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
Placebo Gel (Surgilube)
n=100 participants at risk
This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
|
|---|---|---|
|
Nervous system disorders
dizziness
|
9.0%
9/100 • Number of events 9
|
12.0%
12/100 • Number of events 12
|
|
Gastrointestinal disorders
nausea
|
8.0%
8/100 • Number of events 8
|
4.0%
4/100 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place